Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study

Not Applicable

Completed

• Conditions: Adherence, Patient

• Registration Number: NCT04032730
• Lead Sponsor: Centre for the AIDS Programme of Research in South Africa

Brief Summary

The goal of the proposed study is to enhance adherence and retention in care for M/XDR-TB HIV patients through enhanced standard of care, targeted transition to outpatient medication self-administration prior to hospital discharge, and use of community adherence groups, with an overarching goal of promoting patient engagement in a care continuum.

Detailed Description

Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people living with HIV (1). Globally, the incidence of multidrug-resistant tuberculosis (MDR-TB) and extensively drug resistant tuberculosis (XDR-TB), the most drug-resistant forms of TB, has approximately doubled over the past fifteen years (1-3). Nowhere has this increased incidence generated more concern than in South Africa where interactions between TB and generalized HIV epidemics are causing 'explosive' TB incidence (4-6) and case-fatality are threatening to undermine the progress reached with antiretroviral therapy (ART) (7, 8).

Medication adherence, a key predictor of outcomes in M/XDR-TB and HIV treatment, is understudied in high burden TB-HIV settings (9-11). Patient losses during transitions in the care continuum are frequent (12), increase mortality and limit control of the linked epidemics. Demands of M/XDR-TB HIV treatment are severe including extraordinary pill burden, severe adverse effects, lengthy treatment, isolation and stigma with few parallels in modern medicine (13-15).

Study Timeline

• Study Start: 2018-04-29
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-25
• Primary Completion: 2021-09-28
• Study Completion: 2022-12-05
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

1. Age ≥ 18 years
2. MTB culture positive with at least isoniazid and rifampicin resistance OR Molecular drug susceptibility test confirming resistance to at least isoniazid and rifampicin OR Polymerase chain reaction test (Xpert MTB/RIF) result showing MTB positive and RIF resistance. OR MTB positive with Rifampicin monoresistance
3. Initiating treatment for M/XDR-TB which includes Bedaquiline (BDQ) or Moxifloxacin/Levaquin
4. Have capacity for informed consent
5. HIV Positive Patients: on ART or initiating ART within the following 4 weeks as per clinician recommendation

Exclusion Criteria

1. Pregnancy
2. Prisoners
3. Discretion of IOR or clinician

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TB treatment outcomes	9-24 months	The number of participants with TB treatment outcomes as assessed by death or culture conversion.
Adherence in M/XDR-TB HIV outcomes	9-24 months	The number of participants that are adherent to their TB and ARV medication as assessed by: * the use of wisepill device (electronic pill box). 2 wisepill devices are provided to participants in the intervention arm, one for their ART medication and one for their TB medication (namely Bedaquiline).; * By self reporting via 7-day recall and 30-day recall; * By self reporting via Visual analogue scale
Retention in care	9-24 months	Retention in care will be assessed by loss to follow-up.

Trial Locations

Locations (1)

King Dinuzulu Hospital; 🇿🇦 Durban, KwaZulu Natal, South Africa